Impact of Actinic Keratosis on patient-reported AK symptoms, emotions and functioning measured using Skindex-16, among patients with Actinic Keratosis administered tirbanibulin in real-world community practices across the U.S. (PROAK Study)

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Darrell Rigel
Mark Lebwohl
Todd Schlesinger
April Armstrong
Brian Berman
Neal Bhatia
James Del Rosso
Leon Kircik
Vishal A. Patel
Siva Narayanan
Volker Koscielny
Ismail Kasujee


Actinic Keratosis, AK, PROAK, PROs, Patient Reported Outcomes, RWE, Real World Evidence, Skindex-16, Emotions, Functioning, Symptoms, QOL, Quality of Life, Tirbanibulin


Objectives: Actinic Keratosis (AK) has been shown to negatively affect emotional functioning and skin-related quality of life of patients. Impact of tirbanibulin treatment in alleviating AK disease burden in patients with AKs is not adequately understood. Objective of the analysis is to evaluate changes in patient-reported AK symptoms, emotions, and functioning, among patients with AKs treated with tirbanibulin in community practices across the U.S. Methods: A single-arm, prospective cohort study (PROAK) was conducted among adult patients with AKs on the face or scalp who were newly initiated with tirbanibulin treatment in real-world community practices in the U.S, as part of usual care. Patients and clinicians completed surveys and clinical assessments at baseline, week-8 (timeframe for main endpoints) and week-24. Skindex-16, completed at baseline and week-8, is a 16-item survey with 3 domains: symptoms (items 1-4), emotions (items 5-11) and functioning (items 12-16), with each item scored on a seven-point adjectival response scale, with a potential score of 0 (never bothered) to 6 (always bothered). Changes from baseline in proportion of patients reporting a score of 0 or 1 (never or least bothered; i.e., least disease burden) was analyzed for all Skindex-16 items at week-8. Results: A total of 290 patients with AKs completed the study assessments at week-8 (female: 31.38%; history of skin cancer: 61.72%; Fitzpatrick skin type: I: 7.59%, II: 71.38%, III: 18.62%, IV: 1.38%, V: 1.03%). Patient self-reported skin-texture was – dry: 39.66%, smooth: 47.59%, rough: 19.66%, bumpy: 18.62%, scaly: 35.17%, blistering/peeling: 6.55%. Within symptoms domain of Skindex-16 related to itching, burning/stinging, hurting, and irritation, proportion of patients reporting “never or least bothered” increased significantly for each item at week-8 (p<0.0001). Within emotions domain of Skindex-16 related to persistence of condition, worries about skin, appearance, frustration, embarrassment, being annoyed, and feeling depressed, proportion of patients reporting “never or least bothered” increased significantly for each item at week-8 (p<0.0001). Within functioning domain of Skindex-16 related to interactions with others, desire to be with others, show affection, effect on daily activities, and effect on work or enjoyable activities, proportion of patients reporting “never or least bothered” increased significantly for each item at week-8 (p<0.0001). Conclusion: Patients with AKs who used once-daily tirbanibulin treatment for 5-days reported a significant reduction in the AK burden, as indicated by the improvement in AK symptoms and emotional/functional impact, at week-8.



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